Medical device regulations in Georgia have significantly tightened in recent years, aligning closely with EU standards. The import and sale of medical products (equipment, consumables, diagnostic tools) require strict compliance with regulatory requirements, including state registration, labeling, and quality control. Improperly documented imports often lead to cargo being held at customs, which is critical for perishable or urgently needed medical supplies. Additionally, certain categories of medical goods enjoy tax exemptions (e.g., VAT exemption), the utilization of which requires knowledge of specific codes and documentation. Consequently, this field demands a synthesis of pharmaceutical law and customs/tax regulations.
What Do Medical Device Regulation Services Cover?
Specialists on Legal.ge assist importers and distributors in gaining smooth market access for their products. The services include:
- State Registration: Registering medical devices with the Regulation Agency of the Ministry of Health, preparing dossiers, and submission.
- Customs Classification: Correctly classifying goods (assigning HS codes) to determine if they qualify for VAT exemption or require special permits.
- Labeling and Marking Consultation: Preparing Georgian labels and instructions in compliance with legislation, which is mandatory for sale.
- Permit Acquisition: Obtaining import permits for equipment subject to special control (e.g., containing radioactive sources).
- Compliance Audit: Reviewing existing processes to determine the company's readiness for inspections conducted by the regulator.